Colorectal Cancer News

New Phase II Study for Patients with Metastatic Colorectal Cancer

Clinicaltrials.gov identifier NCT01111604

This phase II trial is for patients with metastatic colorectal cancer that will compare disease progression, response, and survival rates among patients receiving standard therapy versus patients receiving standard therapy plus one of two new active agents (IMC-1121B or IMC-18F1).

Patients with metastatic colorectal cancer will be randomized to three study groups. In all three groups, patients will receive the standard of care with FOLFOX-6. One group will receive FOLFOX-6 only. A second group will receive FOLFOX-6 plus IMC-1121B (Ramucirumab). A third group will receive FOLFOX-6 plus IMC-18F1.

Patients who have progressed on irinotecan-based first line therapy are eligible for this trial (FOLFIRI or FOLFIRI plus bevacizumab). Blood samples will be required to determine the concentrations of these experimental agents at various time points after administration through the cycles of therapy. A total of 150 patients will be enrolled in the trial, and the trial is expected to be complete in June 2013. This is a drug industry trial sponsored by ImClone LLC.